LCP 02.001.328Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982027733), received between Jan 31, 2020 and Jan 31, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K041911); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION DUE TO BROKEN LOCKING COMPRESSION PLATE (LCP) CURVED CONDYLAR PLATE. IT HAS ELEVEN (11) SCREWS. THERE WERE NO FRAGMENTS GENERATED FROM THE BROKEN DEVICE. BROKEN DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND REPLACED WITH ANOTHER PLATE. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 8). UNKNOWN CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 3). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 9653013 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041911. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2014 · Jul 30, 2013 · Terminated
  Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.